Following an application from Cargill R&D Centre Europe, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to sugar-free hard confectionery with at least 90% erythritol and reduction of dental plaque, which reduces the risk of caries.
The scope of the application was proposed to fall under a health claim referring to disease risk reduction.
The general approach of the NDA Panel for the evaluation of health claims applications is outlined in the EFSA general guidance for stakeholders on health claim applications and the EFSA guidance on the scientific requirements for health claims related to bone, joints, skin and oral health.
The food proposed by the applicant as the subject of the health claim is Zerose® erythritol sugar free hard confectionery. The Panel considers that the food, sugar-free hard confectionery with at least 90% erythritol, which is the subject of the health claim, is sufficiently characterised.
The claimed effect proposed by the applicant is ‘reduction of dental plaque which reduces the risk of caries’. The target population proposed by the applicant is the general population aged 5 years and older. In relation to the disease (dental caries) that is the subject of the health claim, the Panel considers that a clinical assessment of dental caries using the ICDAS II classification is an appropriate outcome variable to assess the incidence of the disease in intervention studies conducted in children. The applicant proposes three outcome variables to be used for the assessment of the risk factor(s) in human studies: (a) the weight of freshly collected dental plaque (i.e. collected from all available tooth surfaces during a timed 3-min period); (b) salivary and plaque counts of Streptococcus mutans and (c) chemical analysis of dental plaque (i.e. plaque sugars, organic acids and polyols).
The Panel considers that, in the context of this application, the weight of dental plaque, and/or the counts of S. mutans in dental plaque, and/or the concentration of organic acids in plaque (primarily acetic acid and lactic acid) can be considered as risk factor(s) in the development of dental caries, as long as evidence is provided that the consumption of the food that is the subject of the health claim reduces one or more of the proposed risk factors and the incidence of dental caries.
The applicant identified two human intervention studies (reported in four publications) as being pertinent to the claim, of which only one study investigated the effect of consuming sugar-free hard confectionery with 90% erythritol on the incidence of dental caries.
The first study was designed as a randomised, three-arm, double-blind parallel trial which investigated the effect of consuming chewable hard candies (four 0.7-g candies three times per day) with 90% erythritol, xylitol or sorbitol on school days for three consecutive years in school children aged 8–9 years at baseline. The intended daily intake of each sugar alcohol was approximately 7.5 g. Children were followed-up for another three years after the end of the intervention.
No significant differences in enamel caries teeth (Dd1–3Tt) and surfaces (Dd1–3Ss), dentin caries teeth (Dd4–6Tt) and surfaces (Dd4–6Ss) or caries indices (D4–6 MFT + d4–6mft and D4–6MFS + d4–6mfs) were observed in mixed or permanent dentition between the erythritol and the sorbitol (control) groups at any time during the study, or in permanent dentition during the 3-year follow-up.
The second study provided by the applicant was a four-arm parallel study reporting on the effects of consuming either erythritol, xylitol or sorbitol sugar-free hard confectionery for 6 months on dental plaque (i.e. plaque index, plaque fresh weight, counts of ‘mutans streptococci’ in plaque and saliva) as compared to no treatment in a group of adolescents aged 16–19 years. Incidence of dental caries was not assessed. The applicant also provided one study in animals and five in vitro studies in support of the mechanisms by which the food that is the subject of the health claim could exert the claimed effect.
The Panel considers that, in the absence of evidence for an effect on the incidence of dental caries in vivo in humans, the results of the human studies investigating the effects of sugar-free hard confectionery with at least 90% erythritol on the proposed risk factors for dental caries and the studies provided on the mechanisms by which the food could exert the claimed effect cannot be used as a source of data for the scientific substantiation of the claim.
In weighing the evidence, the Panel took into account that one human intervention study (reported in three publications) with some methodological limitations (e.g. data analysis in completers only) did not show an effect of sugar-free hard confectionery with at least 90% erythritol on the incidence of dental caries in children on either mixed or permanent dentition.
On the basis of the data provided, the Panel concludes that a cause and effect relationship has not been established between the consumption of sugar-free hard confectionery with at least 90% erythritol and reduction of dental plaque which reduces the risk of dental caries.
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